Label: Information for the User

Repaglinide Combix 1 mg Tablets

Read this label carefully before starting to take the medicine, as it contains important information for you

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this label. See section 4.

Repaglinida Combix is a medicationoral antidiabetic that contains repaglinide, which helps your pancreas to produce more insulin and lower your blood sugar (glucose).

Thetype 2 diabetesis a disease in which the pancreas does not produce enough insulin to control the level of sugar in the blood or in which the body does not respond normally to the insulin it produces.

Repaglinida Combix is used to control type 2 diabetes in adults, as a complement to diet and exercise: treatment should be initiated if diet, physical exercise, and weight reduction alone have not been sufficient to control (or decrease) the level of sugar in the blood. Repaglinida Combix can also be administered with metformin, another diabetes medication.

It has been shown that Repaglinida Combix reduces the level of blood sugar, which contributes to preventing diabetes complications.

Do not take Repaglinida Combix

• if you areallergicto repaglinide or any of the other ingredients in this medicine (listed in section 6)
• if you havetype 1 diabetes
• if your body has a high level of acid (diabetic ketoacidosis)
• if you have aserious liver disease
• if you are takinggemfibrozil(a medicine that lowers blood fat levels)

Warnings and precautions

Consult your doctor or pharmacist before starting to take Repaglinida Combix:

• if you haveliver problems. Repaglinida Combix is not recommended for patients with moderate liver disease. Repaglinida Combix should not be taken if you have a serious liver disease (seeDo not take Repaglinida Combix)
• if you havekidney problems. Repaglinida Combix should be taken with caution
• if you are about to undergo amajor surgical procedureor have recently had aserious illnessorinfection. In these circumstances, blood sugar control may not be achieved
• if you areunder 18 yearsorover 75 years. Repaglinida Combix is not recommended. It has not been studied in these age groups

Consult your doctor ifany of the cases mentioned occur. Repaglinida Combix may not be indicated for you. Your doctor will advise you.

Children and adolescents

Do not take this medicine if you are under 18 years.

If you have a hypoglycaemia (low blood sugar)

You may have a hypoglycaemia if your blood sugar level is too low. This can occur if:

• you take too much Repaglinida Combix
• you do more physical exercise than usual
• you take other medicines or have liver or kidney problems (see other sections of section 2.What you need to know before starting to take Repaglinida Combix)

Warning signs of a hypoglycaemiacan appear suddenly and may include: cold sweat, pale and cold skin, headache, palpitations, nausea, excessive appetite, temporary visual disturbances, fatigue, unusual tiredness and weakness, nervousness or tremor, anxiety, confusion, and difficulty concentrating.

If your blood sugar level is low or you feel you are going to have a hypoglycaemia: take glucose tablets or a sugary product or drink and then rest.

When the symptoms of hypoglycaemia disappear or when blood sugar levels stabilise, continue treatment with Repaglinida Combix.

Inform others that you are diabetic and that if you lose consciousness due to a hypoglycaemia, they should lay you on your side and seek immediate medical assistance. Do not give you anything to eat or drink, as you may choke:

• if severe hypoglycaemiais not treated, it can cause brain damage (temporary or permanent) and even death.
• if a hypoglycaemialeaves you unconscious or if you have repeated hypoglycaemias, inform your doctor. You may need to adjust the amount or dosage of Repaglinida Combix, diet, or exercise.

If your blood sugar level is very high

Your blood sugar level may be very high (hyperglycaemia). This can occur:

• if you take too little Repaglinida Combix
• if you have an infection or fever
• if you eat more than usual
• if you do less exercise than usual

Warning signs of a very high blood sugar levelappear gradually. These include: frequent urination, thirst, dry skin, and a feeling of dryness in the mouth. Inform your doctor. You may need to adjust the amount of Repaglinida Combix, diet, or exercise.

Taking Repaglinida Combix with other medicines

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medicine.

If your doctor prescribes it, you can take Repaglinida Combix with metformin, another diabetes medicine.

If you take gemfibrozil (used to lower blood fat levels), do not take Repaglinida Combix.

Your body's response to Repaglinida Combix may change if you take other medicines, especially:

• monoamine oxidase inhibitors (MAOIs) (for depression treatment)
• beta-blockers (for hypertension or heart disease treatment)
• ACE inhibitors (for heart disease treatment)
• salicylates (e.g. aspirin)
• octreotide (for cancer treatment)
• non-steroidal anti-inflammatory drugs (NSAIDs) (a type of analgesic)
• steroids (anabolic steroids and corticosteroids - for anemia or to treat inflammation-)
• oral contraceptives (to prevent pregnancy)
• thiazides (diuretics)
• danazol (for breast cysts and endometriosis treatment)
• thyroid medicines (for low thyroid hormone levels)
• sympathomimetics (for asthma treatment)
• clarithromycin, trimethoprim, rifampicin (antibiotics)
• itraconazole, ketoconazole (antifungal medicines)
• gemfibrozil (to treat high blood fat levels)
• ciclosporin (to suppress the immune system)
• deferasirox (to reduce chronic iron overload)
• phenytoin, carbamazepine, phenobarbital (used to treat epilepsy)
• St. John's Wort(herbal medicine)
• clopidogrel (to prevent blood clot formation)

Taking Repaglinida Combix with alcohol

Alcohol can alter Repaglinida Combix's ability to lower blood sugar levels.

Be aware of the warning signs of hypoglycaemia.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, consult your doctor before using this medicine.

You should not take Repaglinida Combix if you are pregnant or planning to become pregnant.

You should not take Repaglinida Combix if you are breastfeeding.

Driving and operating machinery

Your ability to drive cars and operate machinery may be affected if your blood sugar level is low or high. Be aware that you may put yourself or others at risk. Consult your doctor about the possibility of driving a car if:

• you have frequent hypoglycaemias

you have few or no hypoglycaemia symptomsor it is difficult for you to recognise them.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in doubt, consult your doctor again.

Your doctor will determine your dosage.

• Normally,The initial doseis 0.5 mg taken just before each main meal. The tablets must be taken with a glass of water just before or within 30 minutes before each main meal.
• The dosage may be adjusted by your doctor up to 4 mg, which must be taken just before or within 30 minutes before each main meal. The maximum recommended dose is 16 mg per day.

Do not take more Repaglinida Combix than your doctor has recommended.

If you take more Repaglinida Combix than you should

If you take too many tablets, your blood sugar may become too low and cause hypoglycemia. Please read what hypoglycemia is and how to treat it in the sectionif you have hypoglycemia.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to take Repaglinida Combix

If you forget to take a dose, take the next dose when it is due. Do not take a double dose to compensate for the missed doses.

If you interrupt treatment with Repaglinida Combix

Be aware that the desired effect will not be achieved if you stop taking Repaglinida Combix. Your diabetes may worsen. If any change in your treatment is necessary, consult your doctor beforehand.

If you have any doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

Hypoglycemia

The most frequent adverse effect is hypoglycemia, which may affect up to 1 in 10 people (see Hypoglycemia in section 2). Hypoglycemic reactions are usually mild or moderate but occasionally may lead to loss of consciousness or hypoglycemic coma. If this occurs, seek immediate medical assistance.

Allergy

Allergic reactions are very rare (may affect up to 1 in 10,000 people). Symptoms such as swelling, difficulty breathing, palpitations, symptoms of dizziness, and sweating, may be signs of anaphylactic reaction. Contact your doctor immediately.

Other Adverse Effects

Frequent(may affect up to 1 in 10 people):

• Abdominal pain
• Diarrhea

Rare(may affect up to 1 in 1,000 people):

• Acute coronary syndrome (but may not be due to the medication)

Very Rare(may affect up to 1 in 10,000 people):

• Vomiting
• Constipation
• Visual disturbances
• Severe liver problems, abnormal liver function, such as elevated liver enzymes in the blood

Frequency Not Known(the frequency cannot be estimated from the available data):

• Hypersensitivity (such as hives, itching, redness, and swelling)
• Nausea

Ifyou experience adverse effects, consult your doctor or pharmacist, even if they are adverse effects that do not appear in this prospectus.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date that appears on the box and on the blister pack after CAD. The expiration date is the last day of the month indicated.

Medicines should not be disposed of through drains or in the trash. Dispose of the packaging and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medicines. By doing so, you will help protect the environment.

Composition of Repaglinida Combix

• The active ingredient is repaglinide. Each tablet contains 1 mg of repaglinide.
• The other components are: microcrystalline cellulose (E460i), calcium phosphate, cornstarch, potassium polacrilex, povidone K30, 99.5% glycerol (E422), magnesium stearate (E470b), poloxamer 188, meglumine, and yellow iron oxide (E172).

Appearance of the product and content of the container

The tablets are yellow, round, biconvex, approximately 6 mm in diameter, and have a groove on one face.

The tablets can be divided into equal doses.

Repaglinida Combix is available in containers of 30, 90, 120, and 270 tablets in blisters and in containers of 90 and 270 tablets in bottles.

Only some sizes of containers may be commercially available.

Holder of the marketing authorization

Laboratorios Combix, S.L.U.

C/ Badajoz 2, Edificio 2

28223 Pozuelo de Alarcón, Madrid

Spain

Responsible for manufacturing

PharmaPath S.A.

28is Oktovriou 1,

Agia Varvara, 123 51,

Greece

This medicine is authorized in the Member States of the European Economic Area with the following names:

SpainRepaglinida Combix 1 mg tablets EFG

This leaflet was approved in February 2016

The detailed and updated information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/